Advisory Committee on Infant Mortality; Notice of Meeting, 64524-64525 [2012-25947]
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64524
Federal Register / Vol. 77, No. 204 / Monday, October 22, 2012 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FDA Form No.
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Form FDA 3397 ......................................................................
260
15.89
4,131
0.5 (30 min.)
2,065.5
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–25898 Filed 10–19–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Arthritis Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
wreier-aviles on DSK5TPTVN1PROD with
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Arthritis
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on December 20, 2012, from 8 a.m.
to 5 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(rm. 1503), Silver Spring, MD 20993–
0002. Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Yvette Waples, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg, 31, rm 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, email:
AAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
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modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: The committee will discuss
new drug application (NDA) 22151,
rintatolimod injection (proposed trade
name AMPLIGEN), submitted by
Hemispherx Biopharma, Inc., for the
treatment of patients with chronic
fatigue syndrome.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before December 6, 2012.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2:30 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before
November 28, 2012. Time allotted for
each presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
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open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by November 29, 2012.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Yvette
Waples at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: October 16, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–25878 Filed 10–19–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Committee on Infant
Mortality; Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: Advisory Committee on Infant
Mortality (ACIM).
Dates and Times: November 14, 2012, 8:30
a.m.–5:30 p.m.; November 15, 2012, 8:30
a.m.–3:30 p.m.
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Federal Register / Vol. 77, No. 204 / Monday, October 22, 2012 / Notices
Place: L’Enfant Plaza Hotel, 480 L’Enfant
Plaza SW., Washington, DC 20024, (202)
484–1000.
Status: The meeting is open to the public
with attendance limited to space availability.
Purpose: The Committee provides advice
and recommendations to the Secretary of
Health and Human Services on the following:
Department of Health and Human Services’
programs that focus on reducing infant
mortality and improving the health status of
infants and pregnant women; and factors
affecting the continuum of care with respect
to maternal and child health care. It includes
outcomes following childbirth; strategies to
coordinate the myriad federal, state, local
and private programs and efforts that are
designed to deal with the health and social
problems impacting on infant mortality; and
the implementation of the Healthy Start
Program and Healthy People 2020 infant
mortality objectives.
Agenda: Topics that will be discussed
include the following: HRSA Update;
Maternal and Child Health Bureau Update;
Healthy Start Program Update; Updates from
Partnering Agencies and Organizations; and
ACIM’s recommendations for the HHS
National Strategy to Address Infant Mortality.
Proposed agenda items are subject to
change as priorities dictate.
Time will be provided for public
comments limited to five minutes each.
Comments are to be submitted in writing no
later than 5:00 p.m. ET on October 31, 2012.
FOR FURTHER INFORMATION
CONTACT:Anyone requiring information
regarding the Committee should contact
Michael C. Lu, M.D., M.P.H., Executive
Secretary, ACIM, Health Resources and
Services Administration, Room 18–05,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857, Telephone: (301) 443–
2170.
Individuals who are submitting public
comments or who have questions regarding
the meeting and location should contact
David S. de la Cruz, Ph.D., M.P.H., ACIM
Designated Federal Official, HRSA, Maternal
and Child Health Bureau, telephone: (301)
443–0543, email:
David.delaCruz@hrsa.hhs.gov.
Dated: October 16, 2012.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2012–25947 Filed 10–19–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
wreier-aviles on DSK5TPTVN1PROD with
National Institute on Deafness and
Other Communication Disorders;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
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provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Deafness and Other Communication
Disorders; Special Emphasis Panel; VSL
Fellowships.
Date: November 1, 2012.
Time: 12:00 p.m. to 1:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Executive Plaza, EPS, Room 400C,
6120 Executive Blvd., Bethesda, MD 20852.
Contact Person: Christine A. Livingston,
Ph.D., Scientific Review Officer, Division of
Extramural Activities, National Institutes of
Health/NIDCD, 6120 Executive Blvd., MSC
7180 Bethesda, MD 20892, (301) 496–8683,
livingsc@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.173, Biological Research
Related to Deafness and Communicative
Disorders, National Institutes of Health, HHS)
Dated: October 15, 2012.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–25834 Filed 10–19–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel Tuberculosis
Infection in the Elderly.
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64525
Date: November 19, 2012.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Suite 2C212, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Elaine Lewis, Ph.D.,
Scientific Review Branch, National Institute
on Aging, Gateway Building, Suite 2C212,
MSC–9205, 7201 Wisconsin Avenue,
Bethesda, MD 20892, 301–402–7707,
elainelewis@nia.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: October 15, 2012.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–25835 Filed 10–19–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Eye Institute; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Eye Institute
Special Emphasis Panel, NEI Career
Development and Conference Grant
Applications—Visual Processing and Low
Vision.
Date: November 8, 2012.
Time: 1:00 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5635
Fishers Lane, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Anne E Schaffner, Ph.D.,
Chief, Scientific Review Officer, Division of
Extramural Research, National Eye Institute,
National Institutes of Health, 5635 Fishers
Lane, Suite 1300, MSC 9300, 301–451–2020,
aes@nei.nih.gov.
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Agencies
[Federal Register Volume 77, Number 204 (Monday, October 22, 2012)]
[Notices]
[Pages 64524-64525]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-25947]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Advisory Committee on Infant Mortality; Notice of Meeting
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), notice is hereby given of the following
meeting:
Name: Advisory Committee on Infant Mortality (ACIM).
Dates and Times: November 14, 2012, 8:30 a.m.-5:30 p.m.;
November 15, 2012, 8:30 a.m.-3:30 p.m.
[[Page 64525]]
Place: L'Enfant Plaza Hotel, 480 L'Enfant Plaza SW., Washington,
DC 20024, (202) 484-1000.
Status: The meeting is open to the public with attendance
limited to space availability.
Purpose: The Committee provides advice and recommendations to
the Secretary of Health and Human Services on the following:
Department of Health and Human Services' programs that focus on
reducing infant mortality and improving the health status of infants
and pregnant women; and factors affecting the continuum of care with
respect to maternal and child health care. It includes outcomes
following childbirth; strategies to coordinate the myriad federal,
state, local and private programs and efforts that are designed to
deal with the health and social problems impacting on infant
mortality; and the implementation of the Healthy Start Program and
Healthy People 2020 infant mortality objectives.
Agenda: Topics that will be discussed include the following:
HRSA Update; Maternal and Child Health Bureau Update; Healthy Start
Program Update; Updates from Partnering Agencies and Organizations;
and ACIM's recommendations for the HHS National Strategy to Address
Infant Mortality.
Proposed agenda items are subject to change as priorities
dictate.
Time will be provided for public comments limited to five
minutes each. Comments are to be submitted in writing no later than
5:00 p.m. ET on October 31, 2012.
FOR FURTHER INFORMATION CONTACT:Anyone requiring information
regarding the Committee should contact Michael C. Lu, M.D., M.P.H.,
Executive Secretary, ACIM, Health Resources and Services
Administration, Room 18-05, Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857, Telephone: (301) 443-2170.
Individuals who are submitting public comments or who have
questions regarding the meeting and location should contact David S.
de la Cruz, Ph.D., M.P.H., ACIM Designated Federal Official, HRSA,
Maternal and Child Health Bureau, telephone: (301) 443-0543, email:
David.delaCruz@hrsa.hhs.gov.
Dated: October 16, 2012.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2012-25947 Filed 10-19-12; 8:45 am]
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